Unit 17: Solubility and Solubility Enhancement
Solubility is a key determinant of drug absorption and bioavailability, influenced by physicochemical and environmental factors. Enhancement techniques range from conventional methods like salt formation to advanced approaches such as nanocrystals, solid dispersions, and hot-melt extrusion.
Definition
Solubility is the maximum amount of solute that can dissolve in a solvent at a specified temperature and pressure to form a homogeneous solution.
Solubility is a critical parameter influencing drug absorption, bioavailability, and therapeutic effectiveness. Poor solubility is a major challenge in formulation development.
Key Points
Impacts dissolution rate and absorption
Essential for oral dosage form performance
USP <1236> provides solubility testing guidelines
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